Ignite Creation Date:
2024-05-05 @ 11:33 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00077363
Status:
COMPLETED
Last Update Posted:
2013-02-27
First Post:
2004-02-10
Brief Title:
Capecitabine and Tipifarnib in Treating Women With Taxane-Resistant Metastatic Breast Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Trial of Capecitabine in Combination With the Farnesyltransferase Inhibitor R115777 Tipifarnib Zarnestra in Patients With Metastatic Breast Cancer
Status:
COMPLETED
Status Verified Date:
2013-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This phase II trial is studying how well giving capecitabine together with tipifarnib works in treating women with taxane-resistant metastatic breast cancer Drugs used in chemotherapy such as capecitabine work in different ways to stop tumor cells from dividing so they stop growing or die Tipifarnib may stop the growth of tumor cells by blocking the enzymes necessary for their growth Giving capecitabine together with tipifarnib may kill more tumor cells
Detailed Description:
PRIMARY OBJECTIVES
I The primary objective of this study is to determine the response rate in patients with taxane-resistant metastatic breast cancer treated with capecitabine plus tipifarnib
SECONDARY OBJECTIVES
I To evaluate toxicity in patients with taxane-resistant metastatic breast cancer treated with capecitabine plus tipifarnib
II To evaluate progression free survival time to treatment failure and overall survival in patients with taxane-resistant metastatic breast cancer treated with capecitabine plus tipifarnib
OUTLINE This is a multicenter study
Patients receive oral tipifarnib twice daily and oral capecitabine twice daily on days 1-14 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity Patients achieving a complete response CR receive 4 additional courses beyond documentation of CR
Patients are followed every 3 months for 2 years and then every 6 months for 1 year
I The primary objective of this study is to determine the response rate in patients with taxane-resistant metastatic breast cancer treated with capecitabine plus tipifarnib
SECONDARY OBJECTIVES
I To evaluate toxicity in patients with taxane-resistant metastatic breast cancer treated with capecitabine plus tipifarnib
II To evaluate progression free survival time to treatment failure and overall survival in patients with taxane-resistant metastatic breast cancer treated with capecitabine plus tipifarnib
OUTLINE This is a multicenter study
Patients receive oral tipifarnib twice daily and oral capecitabine twice daily on days 1-14 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity Patients achieving a complete response CR receive 4 additional courses beyond documentation of CR
Patients are followed every 3 months for 2 years and then every 6 months for 1 year
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CDR0000350219 | REGISTRY | PDQ Physician Data Query | httpsreporternihgovquickSearchU10CA021115 |
| E1103 | None | None | None |
| U10CA021115 | NIH | None | None |